People who purchased the drugs were cured of hepatitis C at
a cost of around $700-$900 in South-East Asia and Eastern Europe, Dr Andrew Hill of St Stephen’s AIDS Trust, London,
reported in three poster presentations at the conference.

Direct-acting antivirals typically cure 90 to 95% of hepatitis
C infections, even in cases where people have advanced liver disease or
previous experience of ineffective treatment. The price of treatment remains a
major barrier to curing hepatitis C for millions of people, and where rationing
of treatment, lack of health insurance or lack of a national treatment
programme deny access to these drugs, people are turning to internet-based
buyer’s clubs to obtain generic versions of direct-acting antivirals.

Generic versions of direct-acting antivirals are
manufactured in India under voluntary license from Gilead Sciences, and by
other Indian companies who are not licensees, and in other countries such as
Bangladesh where patents on the products do not exist. The lack of patent
protection allows generic manufacturers to produce their own versions of the
drugs. In many countries it is legal to import drugs for personal use by
ordering them online. In other countries imports of generic
drugs are restricted to those carried through customs by individuals in
quantities sufficient for personal use.

A previous
study by Dr James Freeman of Hobart, Australia, showed very high cure rates
when using generic versions of direct-acting antivirals, and also provided evidence that the
products purchased contained the necessary levels of active drug. The studies
presented this week, in which data supplied by patients and their physicians were analysed by St Stephen’s AIDS Trust in London, measured
virological responses. Two studies identified the generic products used, and one study
was able to measure levels of active ingredients. The preliminary results of
the three studies show cure rates comparable to those achieved with branded
products.

FixHepC Buyer’s Club

The FixHepC Buyer’s Club is an online service which directs
people towards generic sources of hepatitis C drugs and arranges testing of the
drugs to ensure that they contain the correct levels of active ingredients. All
drugs purchased by patients whose data were analysed in this study had been
tested for active ingredients. Patient data were gathered by Dr James Freeman
and analysed by St Stephen’s AIDS Trust. Patients were monitored remotely in
many cases and were distributed across every continent.

The data presented at the International Congress on Drug
Therapy in HIV Infection (HIV Glasgow) represents extended follow-up on 438 of the 448 patients
reported
previously by Dr Freeman.

Fifty-nine per cent of patients contributing data to this
study had less advanced fibrosis (F0-F2), 11% had F3 fibrosis and 27% had
cirrhosis.

Baseline characteristics

Patients

SOF/RBV

(n = 3)

SOF/DCV

(n = 198)

SOF/LDV

(n = 237)

% Male

67%

58%

53%

% Cirrhosis

67%

34%

21%

% GT1

0%

41%

90%

% GT3

0%

46%

5%

+ RBV

100%

11%

9%

Analysis of SVR12 responses by genotype showed that patients
with genotype 3 were substantially less likely to achieve a sustained virologic
response compared to other genotypes. Eighty per cent of genotype 3 patients, predominantly
treated with sofosbuvir/daclatasvir, achieved sustained virologic response
(SVR12), compared to 94% of genotype 1 patients and all patients with genotypes
2, 4, 5 and 6. Overall, 90% of patients who had obtained drugs through the
FixHepC Buyer’s Club and who had completed the 12-week post-treatment follow-up
have achieved sustained virologic response to date.

HCV < 25 IU/ml during study

Patients

SOF/RBV

(n = 3)

SOF/DCV

(n = 198)

SOF/LDV

(n = 237)

RVR

2/2 (100%)

95/111 (86%)

82/98 (84%)

EOT

3/3 (100%)

182/184 (99%)

191/193 (99%)

SVR 4

3/3 (100%)

100/117 (85%)

119/130 (92%)

SVR 12

3/3 (100%)

107/132 (81%)

129/148 (87%)

South-East Asia Buyer’s Club

In Thailand a 12-week course of Sovaldi and Daklinza costs
around $10,000, and is similarly priced in most other countries in the region.
A buyer’s club based in Thailand directed people to online pharmacies in India
to purchase generic versions of sofosbuvir and either ledipasvir or
daclatasvir. Around 85 to 90% of the products supplied were manufactured by
Cipla, one of the largest suppliers of quality-assured antiretroviral drugs for
treatment of HIV. The buyer’s club collected patient data from physicians and
the results were analysed by St Stephen’s AIDS Trust.

Baseline characteristics

Patients

SOF/RBV

(n = 69)

SOF/DCV

(n = 91)

SOF/LDV

(n = 77)

% Male

80%

67%

70%

% Cirrhosis

14%

5%

12%

% GT1

41%

22%

62%

% GT 3

45%

68%

6%

+ RBV

100%

7%

16%

To date, 237 patients have begun treatment. SVR 4 results
are available for 33 and SVR12 results for 24. Results to date show that one
patient failed to achieve rapid virologic response on sofosbuvir/ribavirin, and
one patient failed to achieve an end-of-treatment virologic response on
sofosbuvir/ledipasvir. Two patients on sofosbuvir/ribavirin experienced
virologic rebound between weeks 4 and 12 post-treatment, resulting in a 85%
SVR12 rate to date on this combination. All other patients who have reached 12-week
post-treatment follow-up have achieved sustained virologic response.

Russia and Eastern Europe Buyer’s Club

Sofosbuvir is not available through the Russian hepatitis C
treatment programme and private treatment with the drug costs around $9,500 for
a 12-week course of treatment. In order to obtain affordable treatment, people
with hepatitis C are importing drugs from India, China and Egypt with the
support of the Gepatikta group on Facebook, at a cost of around $700-$900 per
treatment course. Patient data for this study were assembled from private
physicians and AIDS clinics in Russia, Belarus, Estonia, Israel and
Ukraine.

Baseline characteristics

Patients

SOF/RBV

(n = 10)

SOF/DCV

(n = 156)

SOF/LDV

(n = 47)

% Male

60%

56%

53%

% Cirrhosis

0%

11%

13%

% GT1

20%

25%

100%

% GT 3

70%

69%

0%

+ RBV

100%

20%

23%

In the South-East Asia Buyer’s Club the vast majority of
direct-acting antivirals were manufactured by Cipla, but in the Eastern
European Buyer’s Club a wider range of manufacturers supplied products. Just
over half of all drugs purchased were manufactured by the Indian company
Hetero. The Egyptian manufacturer Natco supplied 14% of sofosbuvir and 16% of
sofosbuvir/ledipasvir used by patients, and 7% of daclatsavir. Zydus supplied
11% of daclatasvir, and 16% of daclatasvir used by patients was formulated from
active pharmaceutical ingredients supplied by Chinese manufacturers, a process
also followed by early participants in the FixHepC Buyer’s Club prior to the
availability of generic formulations manufactured in India.

HCV < 25 IU/ml during study

Patients

SOF/RBV

(n = 10)

SOF/DCV

(n = 156)

SOF/LDV

(n = 47)

RVR

7/8 (88%)

100/120 (83%)

34/37 (92%)

EOT

4/4 (100%)

62/62 (100%)

15/15 (100%)

SVR 4

3/3 (100%)

58/58 (100%)

25/25 (100%)

SVR 12

2/2 (100%)

42/43 (98%)

16/16 (100%)

Just over half the patients in this cohort had genotype 3
infection (56%), and 41% had genotype 1 infection. As in South-East Asia, virological
responses were poorer in genotype 3 patients. Eighty-two per cent of people with genotype 3 who
had week 2 measurements of rapid virological response had viral load < 25
IU/ml at this time, compared to 90% of those with genotype 1 and 88% with
genotype 2. A difficulty with making comparisons across these cohort data is
that measurements may be missing at various time points, and people who fail to
respond to treatment may cease, or people may be lost to follow-up as in any
other study. Longer-term follow-up of these large groups of patients will be
needed in order to produce more robust estimates of the proportions achieving
SVR12, as well as any consistent differences by genotype.

NAM's news reporting services from this conference have been made possible thanks to support from Gilead Sciences, Janssen, Merck & Co., Inc., ViiV Healthcare and the Organising Committee of HIV Drug Therapy Glasgow.​

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

close

This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends
checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member
of your healthcare team for advice tailored to your situation.